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Services

01

Supporting every aspect of the pharma product lifecycle from preclinical through commercialization. Also supporting medical and combination devices with 510(k) approval. 

Pharma

INDUSTRIES

02

Supporting CMOs/CDMOs, universities, non-profits, and startups. We also provide scientific due diligence support and assessment. 

Life Sciences

03

Providing quality assurance and control, regulatory strategy and compliance, and laboratory support, including data verification and SOP development. 

Agribusiness

04

SOLUTIONS

Tailored for your needs with comprehensive quotes and available menu pricing

01

Quality Assurance Support

02

Manufacturing Support

03

Regulatory Affairs Support

eCTD Global Publishing

05

Staffing and Contractor Vetting

  • Vendor and partner audits

  • Agency inspection finding remediation

  • Mock inspections 

  • QMS evaluation and automation implementation

  • Batch record and release support

  • GMP training

  • Method development and troubleshooting

  • Technology transfer

  • Formulation and process optimization

  • Phase-appropriate risk assessments

  • Specification justification 

  • Pre-IND through Phase 3

    • Module authoring and review

    • Regulatory Strategy

  • Dossier management and publishing

  • 510(k) Support 

  • Agency interactions

    • Meeting planning and briefing package prep

  • Application integrity reviews

  • RAC-certified publishing staff

  • Document Preparation

  • Links, bookmarks, and cross-references

  • Authoring of sections ____

  • Submission maintenance and management throughout the lifecycle of the submission

  • Structured personnel sourcing and hiring

    • PI

    • DDI Selection

    • TEIQue/PPA

  • Behavioral and technical screening

  • Oversight of contract staff performance

Grayscale image of a hand over a keyboard and compliance images inlaid over the top of the image.
A woman in a cleanroom suit is using pharmaceutical manufacturing equipment.
Grayscale image of symbols related to regulatory support.
Grayscale image of a person in a suit with their finger on a button titled 'publish'.
Grayscale image of a person in a suit with their hand holding a block with the shape of a person on it.

Supported Program Types

01

Grayscale image of a syringe and vial.

Biologics

  • Cell and Gene Therapy

  • mAbs

  • ADCs

  • Biospecifics

  • Vaccines

  • Recombinant Proteins

  • Enzymes

  • mRNA / siRNA

Drugs

02

  • Sterile/aseptic injectables parenteral

  • Solid/Liquid oral dosage

  • Inhalation

  • Ocular

  • Radiological/PET

  • Topicals

Grayscale image of syringes, vials, pills, and a stethoscope.

Devices

03

  • Combination Products

    • Class I

    • Class II

    • Class III

  • Sterile and Aseptic Implantation

  • Ocular

  • Wound Care

  • Birth/Cord/Placental Regenerative

Grayscale image of a woman with a medical device on her head.
Contact Us
Book a Consultation
Jordan Pharma Compliance Logo with CRO / CDMO Support

Turnkey SMEs Across Critical Functions

  • Augment Staffing

  • Fill Short-Term Vacancies

  • Expedite Deliverables

Deliverable Support

  • Technical report authoring and review 

  • Rapid startup with minimal internal burden

  • Clear timelines, deliverables, and hour tracking on a per-client basis

  • Speedy delivery of work product to CRO/CDMO clients to shorten the invoice cycle. 

Regulatory and Quality

  • On-demand quality and regulatory affairs experts

  • Real-time consultation for client program decisions and remediation efforts for Agency findings (483s)

  • Integration into existing workflows and oversite committees

Operational Support

  • Project management support

  •  Process and analytical development experience

  • Capable of supporting multiple projects simultaneously with dedicated project managers

Testimonials

What others say about us

MIchael Silver,

Zanfel Laboritories

Anna Eramo

Chief Medical Officer

LB Pharmaceuticals, Inc

Titik Dain

Research Associate III-Analytical Lead Baxter International, Inc.

“We are a small successful cosmetic company with the goal of bringing an API candidate of our invention from lab scale synthesis through Phase 1. We are climbing Mt. Everest for the first time having only prior experience with small hills, and we were in need of a superb Sherpa. That Sherpa is Peter Jordan.”
I have worked with many professionals throughout my journey, but Peter is a unique one to work with. Peter is one of the best people I had as a partner. I highly recommend his expertise to any person looking for ‘the Expert’ in CMC and Quality Assurance. He is the most qualified person I have met. His ability to tackle any problem is remarkable, and he has helped our team come up with more efficient solutions on different projects.
Peter is a wonderful colleague: very helpful, smart, and a hard worker. Peter has contributed significantly to our projects: analytical support and development; and protein purification process. One of his strengths is his great communication skill. Peter is a good team player; and I would recommend him to any research team.
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